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| Categories | In Vitro Diagnostic Reagents |
|---|---|
| Brand Name: | Zecen |
| Model Number: | CLIA, POClia |
| Certification: | ISO 13485, CE, FSC, |
| Place of Origin: | China, Taizhou |
| MOQ: | 100T (1 BOX),48T (2 BOX) |
| Price: | Negotiable |
| Payment Terms: | L/C, D/A, D/P, T/T, Western Union, MoneyGram |
| Supply Ability: | 10000 T/Month/Project |
| Delivery Time: | 10 Days |
| Packaging Details: | In: Bottle and Strip; Out: Box |
| Packaging: | reagents bottles, reagents strip |
| Storage: | 2~8℃ |
| CV: | <=3% |
| Classification: | Tumor Marker |
| Test throughput: | 120+ tests/hour |
| Validity period: | 18 months |
| Calibration: | 6 points |
| Company Info. |
| Taizhou Zecen Biotech Co.,Ltd. |
| View Contact Details |
| Product List |
Tumor Marker CA15-3 Carbohydrate Antigen 153 for Fully Automatic Immunoassay Analyzer IVD Reagents 100T/box,24T/box
INTENDED USE
The kit has been designed for the quantitative determination of Cancer antigen 15-3 (CA15-3) in human serum.
The method can be used for samples over the range of 1.0～600.0 U/mL .
The test has to be performed on the CIA fully auto analyzer (Including CIA 600, CIA 1200, CIA 1800, CIA2800).
KIT COMPONENTS
Material Supplies
| Reagent Integral for 50 determinations | |
Magnetic beads: BSA buffer with magnetic beads complex with anti-FITC | 1×1.5mL |
| Calibrator A-F: BSA buffer with different levels of CA15-3 antigen | 6×0.25mL |
| CA15-3 Anti: BSA buffer with CA15-3 antibody labeled by FITC and CA15-3 Antibody labeled by AP. | 1×3.0mL |
| Sample Dilution 2:This dilution is composed of Nacl, BSA and Tris buffer with Proclin-300. | 1×12.5mL |
| All reagents are provided ready-to-use. | |
| Reagent Integral for 100 determinations | |
Magnetic beads: BSA buffer with magnetic beads complex with anti-FITC | 1×3.0mL |
| Calibrator A-F: BSA buffer with different levels of CA15-3 antigen | 6×0.5mL |
| CA15-3 Anti: BSA buffer with CA15-3 antibody labeled by FITC and CA15-3 Antibody labeled by AP. | 1×6.0mL |
| Sample Dilution 2:This dilution is composed of Nacl, BSA and Tris buffer with Proclin-300. | 1×25mL |
| All reagents are provided ready-to-use. | |
| Reagent Vials in kit box | 50T | 100T |
| Control 1: BSA buffer with low level of CA15-3 Antigen | 1×0.25 mL | 1×0.5 mL |
| Control 2: BSA buffer with high level of CA15-3 Antigen | 1×0.25 mL | 1×0.5 mL |
| target value refer to Quality Control sheet | ||
Accessories Required But Not Provided
| Substrate | REF: SR2001 |
| System washing solution | REF: WR2001 |
| Probe washing solution | REF: WR2002 |
| product composition | Two points: LH |
| Six points: ABCDEF | |
| Testing method | 1. Treat the calibrator as the sample to be tested, and place it in the sample loading area of the instrument after mixing. Note that when mixing Avoid air bubbles. |
| 2. During the detection, the system detects the luminescence value (RLU value) of each calibration point, and calculates the luminescence value according to the nominal concentration and luminescence value. | |
| The calibration curve is automatically fitted by the instrument. In order to ensure the reliability of the calibration curve, the determination of the calibrator should be | |
| Make a double. | |
| 3. The generated calibration curve can be used for 28 days, but it should be re-calibrated after the following conditions: | |
| ① Change of batch number of supporting testing reagents; | |
| Change of batch number of luminescent substrate | |
| ②The measured value of the quality control product is not within the scope of quality control or the test results are inconsistent with the clinical situation; | |
| ③System for major repairs or maintenance. | |
| Interpretation of test results | 1. For reasons such as methodology or antibody specificity, the same sample was tested using reagents from different manufacturers. |
| Testing with different reagents may give different test results, therefore, the results obtained by testing with different reagents should not be directly | |
| They are compared with each other in order to avoid false medical interpretations. | |
| 2. The quality control product can be used as a reference for the reliability of the current experimental results, and its measured value should be within the | |
| within the range allowed by the quality control sheet. Test results should be based on reference value ranges and other clinical factors and results | |
| Comprehensive judgment, when the test result is close to the upper limit or lower limit of the reference value range, it can be considered | |
| samples for confirmation testing. | |
| Storage and expiration date | Stored at 2-8°C, the product is valid for 12 months. Reagents should be used within 1 month after opening, and stored at 2-8°C away from direct sunlight. |
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